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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC REPLIFORM PUBOVAGINAL SLING MESH, SURGICAL, POLYMERIC

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BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC REPLIFORM PUBOVAGINAL SLING MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 820-244
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Fatigue (1849); Fever (1858); Headache (1880); Nausea (1970); Pain (1994); Rash (2033); Chills (2191); Reaction (2414); Sweating (2444); Ambulation Difficulties (2544); Abdominal Distention (2601); Constipation (3274)
Event Date 09/24/2009
Event Type  Injury  
Event Description

On (b)(6) 2009, i was implanted with repliform tissue regeneration matrix, (lifecell - human dermis allograft) for incontinence. I was not informed as to what was implanted in me until years later when i put all my medical conditions together and realized i had been rejecting this tissue the whole time. I have suffered with rashes, allergies, chest pain, stomach pain, pelvis and right side severe pains to the point where i was unable to walk. It has affected my eyes, teeth, skin, intestines, liver, kidney, muscles, finger/toe nails, hair, you name it. It has affected my whole body. I have severe all over body pain and heat to the point of passing out from it. I be nauseated, sick on my stomach, get chills, headaches, constipation/ diarrhea, high fever, body sweats, and just feel week and very tired at all time. My abdomen stays distended. I have been to doctors and no one can help me. The doctors can put it in but can't remove it. Fda safety report id# (b)(4).

 
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Brand NameBOSTON SCIENTIFIC REPLIFORM PUBOVAGINAL SLING
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key11222585
MDR Text Key228879725
Report NumberMW5098952
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date09/24/2009
Device Catalogue Number820-244
Device LOT NumberB24783018
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/22/2021 Patient Sequence Number: 1
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